Equipment Qualification and Process Validation

What you'll learn?

General FDA GMP information requalification and validation

Equipment Qualification 1. IQ 2. OQ 3. PQ

Computer System Qualification and Part 11

Manufacturing and Cleaning Process Validation 1. Specifications 2. When to test 3. What to test 4. How much to test

Overview of the webinar

FDA current Good Manufacturing Practice (GMP) regulations require that all equipment be qualified and all manufacturing processes, including equipment cleaning processes, be validated. These qualifications and validations must be repeated if changes are made or if problems are encountered, and periodically as necessary. FDA requirements for qualification and validation will be discussed.

Who should attend?

Personnel responsible for equipment qualification

Personnel responsible for computer system qualification

Personnel responsible for manufacturing process validation

Personnel responsible for cleaning validation

Regulatory Affairs, Regulatory Compliance

Quality

Why should you attend?

Lack of adequate qualification or validation is a common FDA inspectional observation and FDA Warning Letter violation. Those involved in equipment qualification, including information technology (IT) and manufacturing and cleaning process validation will benefit from a review of the relevant FDA rules, written and unwritten. Those involved in hosting FDA inspections will also benefit.

Dr. Loren Gelber has more than 40 years in the pharmaceutical industry. She spent her first ten years at FDA, followed by 20 years in Regulatory Affairs and Compliance at various pharmaceutical companies, and the last ten years as a Regulatory Compliance Consultant. During this time she was a member of various groups and committees that worked on many compliance issues. She has published a number of papers and delivered various seminars and talks. Dr. Gelber holds a BA in Biology from Brandeis University, an MS in Chemistry from Brooklyn Polytechnic Institute (now part of NYU) and a PhD in Medicinal Chemistry from Northeastern University School of Pharmacy and Allied Health Professions. She current resides in Charlotte, NC.

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